Status:
COMPLETED
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
Brief Summary
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.
Eligibility Criteria
Inclusion
- Patients is currently clevudine treatment.
- Patients with HBV DNA \< 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patient is pregnant or breast-feeding.
- Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease.
- Patient, in the opinion of the investigator, unsuitable for the study.
- Showing Muscle-related Symptom who any other evidence.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01264107
Start Date
April 1 2009
End Date
April 1 2012
Last Update
July 26 2012
Active Locations (1)
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1
Soon Koo Baik
Wonju, Kangwon-do 162 Ilsan-dong, Wonju, Kangwon-do, South Korea, 220-701